Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) (GO-MORE)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Biological: SC golimumab; Biological: IV golimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975130

2009-011137-26 (EudraCT Number)

CTRI/2009/091/000883 (Registry Identifier)

P06129

Details and patient eligibility

About

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

Full description

Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.

Enrollment: 3,366 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For Part 1:

• Age >=18 years, either sex, any race.

• Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.

• Active disease despite DMARD treatment

• Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.

• Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:

  • Participant must have failed conventional treatment according to the investigator's opinion OR local guidelines.
  • Local guidelines regarding safety screening of anti TNF candidates (ie, tuberculosis [TB] screening and other safety screening such as vaccination, if applicable) must be met. Chest X-ray and either a PPD skin test or QuantiFERON®-TB Gold test are also required.
  • Anamnesis and physical examination must make the participant eligible for anti TNF use and trial participation according to the investigator's judgment.

For Part 2:

• Participant must have completed Part 1 of this trial.

• Participant must have:

  • good or moderate response to SC golimumab at the end of Month 6 compared to Baseline, AND.
  • no DAS28 ESR remission.

• Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.

• The investigator must judge that no safety events (eg, serious adverse events [SAEs], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.

Exclusion criteria

• History of biologic drug use for RA.
• Evidence of active TB. or latent TB that is untreated.
• Moderate to severe heart failure
• Certain inflammatory rheumatic disease other than RA or certain systemic inflammatory condition
• Allergy to latex

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,366 participants in 3 patient groups

SC-GLM50

Experimental group

Description:

In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment.

Treatment:

Biological: SC golimumab

IV GLM 2 mg/kg + GLM50-SC

Experimental group

Description:

After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment.

Treatment:

Biological: IV golimumab

Biological: SC golimumab

GLM50-SC

Experimental group

Description:

After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment.

Treatment:

Biological: SC golimumab